The U.S. Food and Drug Administration (FDA) defines a Laboratory-Developed Test (LDT) as an in vitro diagnostic medical device (IVD) intended for clinical use and designed, manufactured, and used within a single clinical laboratory that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and meets the regulatory requirements under CLIA to perform high complexity testing.
Discover the key points, timeline, EU comparison, and conclusions with our flyer.
Contact us at: [email protected]
Download here:
Share
Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts.
We will be happy to assist you!
